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NCT05996848CompletedPhase 3

A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight

Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-Weekly in Chinese Participants With Overweight or Obesity

Source: ClinicalTrials.gov · Last updated 9 Jan 2026

Brief summary (registry, in English)

This study will look at how well the new medicine CagriSema helps people with excess body weight losing weight compared to a "dummy" medicine and a medicine called semaglutide. Participants will either get CagriSema, a dummy medicine or semaglutide. Which treatment participants get is decided by chance. Participants will take one injection once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1 year.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
300 (actual)
First submitted
10 Aug 2023
Start date
15 Aug 2023
Primary completion date
6 Jan 2025
Lead sponsor
Novo Nordisk A/S
Diseases
Obesity
NCT number
NCT05996848

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 300
  • From 15 Aug 2023 to the primary completion date, 6 Jan 2025
  • 36 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Other illness

  • History of type 1 or type 2 diabetes mellitus
    • For participants with T2D at screening:

Lab values

  • HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
  • Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (mL/min/1.73 m\^2), as measured by the central laboratory at screening

Other

  • For participants without T2D at screening:

Who the study is looking for

  • Male or female
  • Age above or equal to 18 years at the time of signing informed consent
    • Body Mass Index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m\^2) or
    • BMI greater than or equal to 27.0 kg/m\^2 with the presence of at least one weight-related comorbidity including, but not limited to, type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
    • For participants with Type 2 diabetes (T2D) at screening the following criteria also apply:
  • Diagnosed with type 2 diabetes mellitus greater than equal to 180 days before screening
  • Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i)), thiazolidinediones, or sulphonylureas (SUs) as a single agent or in combination) according to local label
  • Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 60 days before screening
  • Glycated Haemoglobin (HbA1c) 7 percent-10 percent (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as measured by the central laboratory at screening

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (36)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chinese People's Liberation Army General Hospital-Endocrinology
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BeijingChinaUnknown status
The First Bethune hospital of Jilin University-Endocrinology
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ChangchunChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
The First People's Hospital of Changde City-Endocrinology
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ChangdeChinaUnknown status
The First People's Hospital Of Changzhou
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ChangzhouChinaUnknown status
Changzhou No.2 People's Hospital
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ChangzhouChinaUnknown status
Chongqing University Three Gorges Hospital
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ChongqingChinaUnknown status
Fujian Medical University Union Hospital-Endocrinology
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FuzhouChinaUnknown status
Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
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HengshuiChinaUnknown status
Huizhou Central People's Hospital-Endocrinology
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HuizhouChinaUnknown status
Jinan Central Hospital
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Ji'nanChinaUnknown status
Jinan Central Hospital
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Jin'anChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
Huashan Hospital Fudan University
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Jingan/ShanghaiChinaUnknown status
Huaihe Hospital of Henan University
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KaifengChinaUnknown status
Huaihe Hospital of Henan University-Endocrinology
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KaifengChinaUnknown status
The First Affiliated Hospital of Henan University of Science
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LuoyangChinaUnknown status
The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
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LuoyangChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University
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NanjingChinaUnknown status
Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine
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ShanghaiChinaUnknown status
Central Hospital of Minhang District-Endocrinology
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ShanghaiChinaUnknown status
Huashan Hospital, Fudan University
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ShanghaiChinaUnknown status
Tongren Hospital Shanghai Jiao Tong University School Of Medicine
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ShanghaiChinaUnknown status
Central Hospital of Minhang District, Shanghai-Endocrinology
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ShanghaiChinaUnknown status
Shanghai Pudong New Area People's Hospital-Endocrinology
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ShanghaiChinaUnknown status
The Second Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
The Second Hospital of Hebei Medical University-Endocrinology
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ShijiazhuangChinaUnknown status
The First Affiliated Hospital of Soochow University-Endocrinology
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SuzhouChinaUnknown status
Suzhou Municipal Hospital-Endocrinology
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SuzhouChinaUnknown status
General Hospital of Tianjin Medical University
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TianjinChinaUnknown status
General Hospital of Tianjin Medical University-Endocrinology
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TianjinChinaUnknown status
The Second Hospital of Tianjin Medical University
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TianjinChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
The Second Affiliated Hospital of Zhengzhou University-Endocrinology
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ZhengzhouChinaUnknown status
The Second Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
The Affiliated Hospital of Jiangsu University
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ZhenjiangChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.